(1) Field of the Invention
This invention relates to compositions and methods for sanitizing or otherwise treating a material. The compositions improve the decontaminating effect of lower alkanols containing 1 to 6 carbon atoms (C1-C6). The compositions disinfect or otherwise sanitize materials such as living tissues (skin, hands, etc.) and inanimate objects (instruments, medical equipment, military and civilian facilities, furniture, papers and printed materials, etc.) of harmful contaminants including, but not limited to chemical warfare agents (VX, mustard, sarin, soman, and tabun), toxins, protozoa, insects (e.g., disease vectors), and pathogenic infectious agents such as bacteria, fungi, viruses, fungal and bacterial spores, and conformationally altered prions (CJD, CWD, BSE, Scrapie).
(2) Description of Prior Art
Germicides include both antiseptics and disinfectants. Antiseptics are germicides applied to living tissue and skin while disinfectants are antimicrobials applied only to inanimate objects. In general, antiseptics are only used on the skin and not for surface disinfection, and disinfectants are not used for skin antisepsis because they may cause injury to skin and other tissues (Rutala and Weber, 2004).
In the past, disinfecting hard surfaces did not require a major decision: You could use a standard powder detergent, bleach or an abrasive powder. End of discussion. Nowadays, hard-surface disinfectants fill entire store aisles and include many specialized products such as bathroom, toilet bowl, glass, ceramic, and kitchen disinfectants of varying kinds, powder and cream scourers, and wipes. One reason for the increase in the number of hard-surface disinfectants is the simple fact that today's hard surfaces include many more types of materials than in the past. For example, in the past, kitchens and bathrooms were primarily finished in wood and other natural surfaces, the modern counterparts contain stainless steel, plastic, fiberglass, ceramics, marble, enamel and porcelain, to name just a few, creating new disinfecting challenges.
On the other hand, recently, there has been renewed emphasis placed on hand hygiene and skin wellness as a result of the Centers for Disease Control and Prevention (CDC)'s “Guideline for Hand Hygiene in Healthcare Settings.” Hand hygiene is the single most important action that can help reduce the spread of infection in hospitals. The CDC's National Nosocomial Infections Surveillance system (NNIS), which collects data from some three hundred hospitals, estimates that in U.S. hospitals there are two million healthcare-associated infections each year accounting for nearly 90,000 deaths annually and $4.5 billion in excess healthcare costs. Current literature documents unacceptably low levels of hand hygiene among healthcare workers (HCWs). There are a number of reasons that impact HCWs compliance to hand washing: (1) lack of easy accessibility to sinks; (2) hand washing causes dry, irritated hands; (3) HCWs are too busy to wash their hands with soap and water often enough; (4) lack of knowledge on when hand hygiene should take place, including casual contact, before and after gloving, etc.
Soaps are detergent-based products that contain esterified fatty acids and sodium or potassium hydroxide. Plain soaps have minimal, if any, antimicrobial activity. In several studies, hand washing with plain soap failed to remove pathogens from the hands of hospital personnel and, occasionally, plain soaps have become contaminated, which may lead to colonization of hands of personnel with gram-negative bacilli (Boyce and Pittet, 2002). Alcohol hand sanitizers have been introduced into healthcare facilities to help HCWs adhere to the recommended hand hygiene guidelines. The CDC legitimated alcohol-based sanitizers because it recognized that the efficacy of alcohol sanitizers was greater than soap and water in reducing the number of germs on hands. However, alcohols are not recommended for sterilizing medical and surgical materials principally because of their lack of sporicidal action and their inability to penetrate protein-rich materials (Rutala and Weber, 2004). The majority of alcohol-based hand antiseptics contain either isopropanol, ethanol, n-propanol, or a combination of two of these products. The majority of studies of alcohols have evaluated individual alcohols in varying concentrations. Other studies have focused on combinations of two alcohols or alcohol solutions containing limited amounts of hexachlorophene, quaternary ammonium compounds, povidone-iodine, triclosan, or chlorhexidine gluconate.
U.S. Pat. No. 4,200,655 to Farah, et al. discloses compositions containing benzyl alcohol as active ingredient intended for topical virucidal use both in vivo and in vitro, especially for use on the hands and especially for preventing transmission of rhinoviruses.
U.S. Pat. No. 4,446,153 to Yang discloses a skin sanitizing composition particularly suited as teat dip or udder wash for dairy cows comprising at least one phenyl alkanol as the antiseptic ingredient.
U.S. Pat. No. 4,695,453 Tuominen, et al. discloses thickened alcoholic antibacterial compositions containing preferably ethanol, propanol, and benzyl alcohol as active ingredients.
U.S. Pat. No. 4,956,175 Maignan, et al. discloses the use of high alcohol content antimicrobial gel compositions for disinfecting hands possessing moisturizing and conditioning agents.
U.S. Pat. No. 6,022,551 to Jampani, et al. discloses an antimicrobial composition comprising an antimicrobial selected from the group consisting of more than 30% by volume alcohol and an effective amount of triclosan; and an effective amount of phenoxy ethanol, an effective amount of benzalkonium chloride or benzethonium chloride; and an effective amount of PHOSPOLIPID CDM. This antimicrobial composition is intended for topical use, such as the hands.
U.S. Pat. No. 6,248,343 to Jampani, et al. relates to antimicrobial compositions which additionally provide therapeutic benefits to the skin. It discloses an antimicrobial composition comprising an antimicrobial selected from the group consisting of more than 30% by volume alcohol, an effective amount of triclosan and mixtures thereof; an effective amount of phenoxy ethanol, an effective amount of benzalkonium chloride or benzethonium chloride; and an effective amount of PHOSPOLIPID CDM; and an effective amount of a naturally occurring plant or extract thereof.
U.S. Pat. No. 6,617,294 to Narula et al. describes a waterless sanitizing hand cleanser comprising an effective amount of alcohol to produce a reduction in microorganisms on the surface of the skin, and emollients or oils for skin moisturizing.
U.S. Pat. Appl. Publication No. 2005/0271595 to Brown discloses a sanitizing composition in the form of a viscous liquid or gel suitable for use as a hand wash composition comprising alcohol, water, a thickener, and antimicrobial agents.
Eur. Pat. Appl. No. 82110376.9 describes an aqueous sterilizing agent for foods or food processing machines and utensils, comprising ethanol and at least one alkaline substance as active ingredients.
Eur. Pat. Appl. No. 83303799.7 relates to aqueous disinfectant solutions with residual biocidal activity for disinfecting hard surfaces in hospitals, comprising from 60 to 80% v/v of C1 to C4 alkanol and at least two antimicrobial agents with a combined concentration in the solution of up to 2% w/v. The first antimicrobial agent is a biguanide compound and the second is a quaternary ammonium compound.
U.S. Pat. No. 4,678,658 to Casey, et al. describes an aerosol spray for use in disinfecting a surface with a fine spray consisting essentially of lower alkyl alcohol, a disinfecting surfactant, a pH sensitive dye, and alkali means for adjusting the pH of the fluid to produce a color in the liquid so upon the fast neutralization by air the dye loses color.
U.S. Pat. No. 5,180,749 to Cusack, et al. discloses an aqueous antimicrobial composition that includes up to about 30 percent by weight ethyl alcohol and about 2 to 5 percent by weight of benzyl alcohol and the remainder to 100% water, and a method of use of the composition for destroying or reducing the number of microbes on an inanimate surface contaminated therewith.
U.S. Pat. Appl. Publication No. 2004/0213750 to Bennett et al. discloses an aqueous hard surface antimicrobial treatment compositions comprising an alcohol and an a pH adjusting agent such the pH range of the composition is from about 7.0 to about 13.0.
U.S. Pat. Appl. Publication No. 2005/0202137 to Awad describes a method for sanitizing red meat for human consumption with an aqueous solution containing lower alkanol and pH modifying agents.
U.S. Pat. No. 6,821,940 to Bullock, et al. describes premoistened wipes containing a substrate and a cleaning composition using toxicologically-acceptable ingredients for treating food such as produce, e.g., fruits and vegetables, edible animal proteins, toys, baby highchairs and the like.
The widespread prevalence of health-care associated diarrhea caused by Clostridium difficile and the recent occurrence in the United States of human Bacillus anthracis infections (11 cases inhalation anthrax and 11 cases of cutaneous anthrax) as a result of the intentional exposure to Bacillus anthracis via contaminated letters has raised concerns regarding the activity of antiseptic and disinfectant agents against spore-forming bacteria. More recently, a laboratory worker acquired anthrax as a result of contact with the surface of vials containing Bacillus anthracis (Page et al., 2002). None of the agents reported in the prior art (including alcohols, chlorhexidine, hexachlorophene, iodophors, PCMX, and triclosan) whether used in antiseptic (hand-wash or hand-rub) preparations or in hard surface disinfectants are reliably sporicidal against Clostridium spp. or Bacillus spp. (Boyce and Pittet, 2002). Moreover, some of these agents (e.g., triclosan) have been linked to antibiotic-resistant bacteria in lab tests. Examples of sporicidal reagents, using relatively high concentrations, include glutaraldehyde, formaldehyde, chlorine oxyacids compounds, peroxy acids, and ethylene oxide. In general, all of these compounds are considered to be toxic. On the other hand, all the chemical antimicrobial agents reported in the prior art (whether sporicidal or not), including ethylene oxide sterilization, ethanol, formalin, beta-propiolactone, detergents, quaternary ammonium compounds, Lysol® disinfecting solution (Reckitt Benckiser, Berkshire, UK), alcoholic iodine, acetone, potassium permanganate, hydrogen peroxide and chlorine dioxide, are ineffective in inactivating the infectivity of conformationally altered infectious prions (Rosenberg et al., 1986) and, their effect on chemical warfare agents is not reported.
Terrorists' threats involving chemical and biological agents, in the context of weapon of mass destruction, are of great concerns to national defense and local law enforcement. For decades, these worries were the quiet domain of U.S. military and national weapon labs, funded by the Department of Energy or the Defense Advanced Research Projects Agency. Future bioterror weapons, scientists say, could include genetically engineered pathogens, prions, and bioregulators (Brown, 2004). During a simulated dirty-bomb attack staged in Seattle in the spring of 2003, one of the lessons learned that responders had nothing to stop the spread of radioactive dust (Weiss, 2005). By the same token, the spread of biological and chemical warfare agents, should a terrorist attack occur, is also very hard, if not impossible, to contain using the technology of the prior art. Should a large scale attack take place, its perpetrators will probably be monitoring the speed and efficacy of the clean-up to decide the value of launching another attack. The anthrax decontamination of the Hart Senate Office Building (Hsu, 2002), using chlorine dioxide, has raised concerns about the readiness to deal with large scale biological attacks. Chlorine dioxide and sodium hypochlorite (household bleach) are used for disinfection of environmental surfaces and are not used as antiseptics applied to skin.
U.S. Pat. No. 6,566,574 to Tadros, et al. teaches the use of an aqueous formulation for neutralizing both chemical and biological agents. The formulation comprises at least two solubilizing agents (a cationic surfactant such as quaternary ammonium salts and a cationic hydrotrope such as tetrapentyl ammonium bromide), at least one reactive compound and water to produce an aqueous formulation. The technical problems associated with this technology include: (1) the need for a different formulation for each specific chemical and biological agent; (2) it has no effect on infectious prions; (3) it cannot be used on living tissues, e.g., topical treatment on skin due to the corrosiveness and toxicity of the reagents used; (4) it cannot be used to decontaminate food products, in case of an agroterrorists attack, because the reagents used are not food grade (GRAS); and (5) it cannot be used in healthcare facilities as a hand sanitizer to replace soap and water.
U.S. Pat. Appl. Publication No. 2004/0022867 to Tucker et al. teaches the use of an aqueous formulation for neutralizing toxants which comprises at least two solubilizing agents (a cationic surfactant and a cationic hydrotrope), a reactive compound (selected from the group consisting of hydrogen peroxide, urea hydrogen peroxide, hydroperoxycarboante, peracetic acid, sodium perborate, sodium peroxypyrophosphate, sodium peroxysilicate, and percarbonate), a bleaching activator, and a sorbent additive. The technical issues associated with this technology include: (1) preparation of the composition in the field due to the instability of the bleaching activator; (2) short shelf life (about eight hours), therefore, it cannot be used in healthcare facilities as a hand sanitizer to replace soap and water; (3) have no effect on infectious prions; (4) it cannot be used on wounds, e.g., topical treatment on wounded skin due to the corrosiveness and toxicity of the reagents used; and (5) it cannot be used to decontaminate food products, in case of an agroterrorist attack, because the reagents used are not food grade (GRAS).
Collectively, the prior art has recognized the real and continuing need for a single, effective, general, safe for humans and the environment, and easy to use formulation for decontaminating both inanimate objects and living tissues of harmful contaminants consisting of chemical warfare (VX, mustard, sarin, soman, and tabun), toxins, insects (e.g., disease vectors), and pathogenic infectious agents such as bacteria, fungi, viruses, fungal and bacterial spores, and conformationally altered prions (CJD, CWD, BSE, Scrapie).